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Role of analgesia given in the peritoneum and through the site of wound before the end of operation in patients undergoing removal of undescended uterus through the vaginal route

Condition category

Surgery

Date applied

23/02/2017

Date assigned

07/03/2017

Last edited

07/03/2017

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsA hysterectomy is a surgical procedure to remove the womb (uterus). This can be done in a number of ways, including through a cut in the top of the vagina (vaginal hysterectomy), through a cut in the lower tummy (abdominal hysterectomy) or through several small cuts in the tummy (laparoscopic hysterectomy). There are many reasons for undergoing a hysterectomy, including cancer and non-cancerous conditions of the female reproductive system. Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.

Who can participate?Women aged between 45 and 70 who are having a vaginal hysterectomy.

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given infections of a fluid in the same places that offers no pain relief (salt water) before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay is recorded.

What are the possible benefits and risks of participating?There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.

Where is the study run from?Benha University Hospital (Egypt)

When is the study starting and how long is it expected to run for?November 2013 to April 2016

Intervention type

Phase

Drug names

Primary outcome measure

Secondary outcome measures

1. Time in hours to get out of bed after operation is measured by nurse responsible for the patient at 8 and 12 hours post-operatively2. Hospital stay in days is measured by nurse at time of discharge of the patient3. Total Narcotic dose (Nalbuphine) is measured by nurse at 1 and 24 hours post-operatively4. Total parentral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by nurse at 24 hours post-operatively5. Number and proportion of patients with nausea and vomiting in the first 24 hours is measured by nurse at 24 hours post-operatively6. Time spent in the post-anethesia care unit is measured by nurse at time of discharge from the post-anethesia care unit

Overall trial start date

01/11/2013

Overall trial end date

15/04/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female 2. 45 to 70 years old3. Scheduled for NDVH for benign indications without need for oophorectomy or vaginal reconstructive surgery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Minimum of 42

Participant exclusion criteria

1. Patient weight less than 50 kg2. Allergy to amide local anathetic3. Dementia or mental retardation to a degree which would interfere with data collection4. Contraindication to non descent vaginal hysterectomy